- Merck & Co. (Durham, NC)
- …goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release , Change Control).- ... ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director, External Manufacturing Operations will also assist… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director, Business System Labeling Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory ... experience strongly preferred, and experience with IT System/Business System Management .Education Min. Requirement: BS/BA or an equivalent certification/experience in… more
- Tris Pharma (Monmouth Junction, NJ)
- …Scientist I, under minimal guidance, performs analytical method validations and release /stability raw materials, in process (IP), finished products (FP) and ... MV lead for assigned projects regularly reporting status/issues to management , conducts laboratory investigations and recommends appropriate Corrective Action… more
- BioAgilytix (San Diego, CA)
- …lead scientific and operational activities in support of preclinical, clinical, and product release studies for our San Diego lab. This role requires deep expertise ... validating bioanalytical assays for support of preclinical, clinical and product release studies.Motivating team by inspiring employees to achieve goals and aligning… more
- Merck & Co. (Rahway, NJ)
- …Responsible and accountable for establishing the timelines for bulk manufacturing needs and release of drug product across assigned program(s) . - Works directly in ... Bulk Drug Product).- - Oversees all bulk drug supply management and ensures proper allocation of drug product as...- At least 8 years of experience in project management . - - At least 5 years of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management of staff in a growing operation in terms of volume/output ... collaboration across relevant cross functional groups to ensure robust production, testing and release of product to patients.Serve as the delegate for the Head of… more
- Repligen (Waltham, MA)
- …which includes all day-to-day activities for product manufacture, test and release including deviation support, root cause analysis, customer complaint management ... CAPA, Validation, Change Controls, and other product life cycle management activities.Partner with cross-functional stakeholders for continuous improvement activities;… more
- Tris Pharma (Monmouth Junction, NJ)
- …strategies and operations, contract negotiations, supplier relationship management , procurement systems functionality/workflows and assurance of compliance ... (ie, purchasing/procurement, warehousing, logistics, etc.) to ensure day to day management and oversight of company's supply chain, logistics and inventory levels… more
- Repligen (Hopkinton, IA)
- …is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for assisting the document control department ... and quality-specific documentation as assigned for purposes of the release of production assemblies.QualificationsBachelor's degree in Biological Science or other… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …ability to drive effective and robust production, testing and release of product to patients.Key Responsibilities Diagnoses, troubleshoot, repair, maintain, ... to: support to manufacturing equipment projects, cost-improvement initiatives, asset management , reliability, and business operations.Support facility project initiatives as… more
- Merck & Co. (Rahway, NJ)
- …Research and industry experience should demonstrate successful application and management of state-of-the-art analytical techniques to solve problems, including ... responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit and promotion planning). Maintaining a… more
- AUROBINDO (Durham, NC)
- …portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality ... the product until it becomes available product for distribution.ResponsibilitiesPeople management responsibilities include hiring and training, planning and assigning… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …relevant cross functional groups to enable robust production, testing and release of product to patients.Key Responsibilities Provides technical expertise in support ... availablePerforms work review, approval and close out of work orders, including management of third-party vendor work, in accordance with established guidelines and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …This individual will partner with Training team members in collaboration with management in Operations to support personalized cell therapy production through safe ... across relevant cross functional groups to enable robust production, testing and release of product to patients.Key Responsibilities Leads, coaches and delivers a… more
- BioAgilytix (Durham, NC)
- …project scope definition, proposal preparation, timelines, scheduling, budget, and revenue management . This role is ideal for someone with a strong background ... scope definition, proposal preparation, timelines, scheduling, budget, and revenue management .Act as primary client contact, presenting data, ensuring clear… more
- Eisai, Inc (Raleigh, NC)
- …with entering events, change controls, and complaints into quality management system.Conduct ongoing tracking, documentation, and reporting of quality goals ... GMP setting (eg, batch record review, SOP writing, auditing, batch release functions, deviation investigation and resolution, as applicable) .Familiarity with… more
- Aequor (Hicksville, OH)
- …lines at the beginning of the shift and at the start of batches to release lines. Monitors lines including correct weights, lot number, expiration date and scans in ... tracking reports. Provides feedback on operator performance. Interacts with production management , mechanics, and Quality Assurance. Participates in training of new… more
- Genmab (NJ)
- …one study are in scope.The Programming Manager will support the Data Management , Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker functions with ... listings, by writing the corresponding programs and ensuring QC before formal release , for the following non-comprehensive list of deliverables: IB, DSUR, briefing… more
- CACI International (Norfolk, VA)
- NTCSS Software Configuration Release Management Specialist Job Category: Engineering and Technical Support Time Type: Full time Minimum Clearance Required to ... Continental US * * * **The Opportunity:** We're seeking an experienced Configuration Release Management professional with a proven track record of consistently… more
- ManTech (Doral, FL)
- ManTech seeks a motivated, career and customer-oriented Senior Release Management Analyst to join our team in Doral, FL. **Responsibilities include but are not ... limited to:** + Senior Release Management Analyst supports the IT asset management process by ensuring IT assets are refreshed, inventoried, and released in… more
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